Annual Meeting & ToxExpo Annual Meeting & ToxExpo Annual ...

EXHIBITOR HOSTED SESSIONS
2:15 PM to 3:15 PM, Room 140A
Machine Learning and Exposure to Modeling in the
Prediction of In Vivo Toxicity from High Content
Screening (HCS) Data
Presented by: Cyprotex Discovery
High content screening (HCS) is a powerful tool for generating
insight into changes arising from exposure of cells to potentially
toxic xenobiotics. Linking these changes to in vivo toxic responses
enables the creation of predictive models for in vivo drug-mediated
toxicity. In this presentation, novel developments in modeling of
drug-induced hepatotoxicity from HCS data will be described.
2:15 PM to 3:15 PM, Room 140B
Automated GLP Infusion Studies: Improved
Process Quality and Labor Utilization
Presented by: Instech Solomon
GLP infusion studies, rife with high labor content and opportunities
for quality improvement, present a classic automation opportunity.
This session describes the costs (investment) and benefits (reduced
labor and improved process data quality) of moving from manual to
Part 11 compatible automated processes.
2:15 PM to 3:15 PM, Room 156
Predictive Analysis of Cell Viability, Apoptosis and
ADME/Tox Properties Using Multiparametric In Vitro
Assays and Human Induced Pluripotent Stem (iPS) Cell-
Derived Cardiomyocytes and Hepatocytes
Presented by: Promega Corporation
This seminar will highlight the use of multiplexed bioluminescent
and fluorescent cell-based assays with human iPS cell-derived
cardiomyocytes and hepatocytes that offer a powerful new approach
to predictive analysis of cell viability, apoptosis and ADME/Tox
properties while enabling streamlined data collection, high data
quality and robust interpretation with biologically relevant human
cell model systems.
3:30 PM to 4:30 PM, Room 140A
The Use of Minipigs in the Development of
New Medicines
Presented by: Ellegaard Göttingen Minipigs A/S
This session provides an overview of marketed drug products where
minipigs were used for safety and/or efficacy assessment. General
trends of use are identified, furthermore its predictivity towards
select clinical adverse reactions is evaluated.
3:30 PM to 4:30 PM, Room 140B
Cryopreserved HepaRG: An Alternative In Vitro
Screening Tool for Human Hepatic Drug Metabolism, and
Safety Applications
Presented by: Life Technologies
The use of primary human hepatoxytes in screening applications is
limited by tissue availability, donor variability, cost and a relative
short lifespan in culture. The use of HepaRG cells solves these
limitations without sacrificing many of the critical hepatocyte traits
such as drug metabolizing enzyme expression, functional transport
proteins, and expression of key nuclear receptor pathways.
WEDNESDAY, MARCH 9
9:15 AM to 10:15 AM, Room 140A
Reproductive and Developmental Toxicity
Testing of Vaccines and Biologics
Presented by: Charles River
The regulatory-required testing of large molecules (vaccines
and biologics) prior to marketing for effects on reproduction and
development of the fetus presents unique problems in the selection
of appropriate species, the timing of treatment, the evaluation of the
response to treatment and the relevance of any findings to humans.
9:15 AM to 10:15 AM, Room 140B
Key Six Sigma Methods Applied to Surgical Services for
Operational Excellence
Presented by: Harlan Laboratories, Inc.
Harlan Laboratories removed non-value added steps and reduced
sources of variation within our rodent surgical services processes
using Lean Six Sigma methods. This was key to achieving
operational excellence as toxicologists and others increased demand
for our outsourced surgical services.
9:15 AM to 10:15 AM, Room 156
Developing Local and Systemic Biologics to Treat
Inflammation of the Lung
Presented by: Huntingdon Life Sciences
Pharmaceutical companies have investigated the respiratory route
as a potential to deliver large molecular weight drugs systemically.
Many companies are continuing to explore the respiratory route for
the treatment of local inflammation. Equally a number of companies
are using systemically delivered drugs to treat inflammation of the
lung. Session highlights issues and assess how the safety might be
addressed.
10:30 AM to 11:30 AM, Room 140B
Overview, Design, and Review of Transgenic
Carcinogenicity Studies
Presented by: BioReliance ® Corporation
Experience and design of Transgenic Carcinogenicity studies;
as well as, date, statistics and histopathology from the largest
database of spontaneous tumors from these studies will be
presented. Discussion will include an overview of the history of
specific models, validations and the efficacy for use in regulatory
submissions.
EXHIBITOR HOSTED SESSIONS
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